BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20966124 · Received December 18, 2024

    Report

    Report Number
    2025587-2024-07402
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ALMUZAINY S, HAMODAT OS, NIZAR S. TRANSCATHETER VERSUS SURGICAL AORTIC VALVE REPLACEMENT: A META-ANALYSIS OF COMPARATIVE O UTCOMES IN LOW- AND INTERMEDIATE-RISK PATIENTS WITH SEVERE AORTIC STENOSIS. HEART VESSELS TRANSPLANT 2024; 8: DOI: 10.24969/HVT.2024.519 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT: OCTOBER 01, 2024 (MONTH AND YEAR VALID). MEDTRONIC TRANSCATHETER VALVE BRANDS USED IN THE STUDY: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO+ (PRODUCT CODE NPT, PMA# P130021), AND EVOLUT FX (PRODUCT CODE NPT, PMA# P130021). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A META-ANALYSIS OF TRANSCATHETER (TAVR) VERSUS SURGICAL AORTIC VALVE REPLACEMENT (SAVR). NINE STUDIES WERE INCLUDED IN THE META-ANALYSIS. MEDTRONIC (COREVALVE/EVOLUT FAMILY) AND NON-MEDTRONIC (VARIOUS) TRANSCATHETER VALVE BRANDS WERE USED IN THE TAVR GROUP, WHILE THE MANUFACTURERS/BRAND NAMES OF THE DEVICES USED IN THE SAVR GROUP WERE NOT DISCLOSED. THE FOLLOWING POST-TAVR ADVERSE OUTCOMES WERE ANALYZED BY THE AUTHORS: STROKE, MYOCARDIAL INFARCTION, PROSTHETIC VALVE ENDOCARDITIS, AND HOSPITAL LENGTH OF STAY. THE AUTHORS ALSO ANALYZED ALL-CAUSE MORTALITY RATES AT THIRTY DAYS, ONE YEAR, AND TWO YEARS AFTER TAVR. HOWEVER, THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115669 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| L